QT Interval, Variation in
Conditions
Brief summary
A single intravenous injection of 0.8mg/kg or 2.8mg/kg Et-26-hcl was given to 18 subjects. The effect of plasma concentration on QT interval was evaluated by C-QTc effect model, and the pharmacokinetic characteristics and safety of ET-26 and etomidate acid were evaluated.
Interventions
DRUGET-26 0.8mg/kg(low-dose) group
In a 2:1 ratio, Placebo was administered with normal saline and ET-26 0.8mg/kg for a duration of 60 ±5 seconds.
DRUGET-26 2.8mg/kg(high dose) group
In a 2:1 ratio, Placebo was administered with normal saline and ET-26 2.8mg/kg for a duration of 60 ±5 seconds.
Sponsors
Ahon Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adult male and female subjects; 2. Age: 18-45 years old; 3. Body weight: body mass index (BMI) between 19.0 and 28.0 kg/m2, with a body weight of at least 50 kg for male subjects and 45 kg for female subjects; 4. voluntarily sign informed consent; 5. Subjects were able to communicate well with investigators and complete the trial in accordance with the protocol.
Exclusion criteria
\- Auxiliary examination: 1. those with clinically significant abnormalities in comprehensive physical examination, vital signs, and laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, serum cortisol); 2. potentially difficult airway (modified Mallampati score III-IV); 3. abnormal and clinically significant hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, or hypocalcemia as judged by the investigator; 4. clinically significant abnormal 12-lead ECG, QTcF≥450 ms, PR interval ≥200 ms, QRS complex duration ≥120ms; 5. hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody positive; Medication history: 6. use of any drugs that inhibit or induce hepatic drug-metabolizing enzymes within 30 days before screening (see Appendix 1 for details); 7. Use of any known QT-prolonging medication within 30 days before screening (see Appendix 1 for details); 8. use of any prescribed medication within 14 days before dose; 9. use of over-the-counter medications, Chinese herbal medicines, or food supplements such as vitamins and calcium supplements within 7 days before administration; History of disease and surgery: 10. have a history of any clinically serious diseases or diseases or conditions considered by the investigators to be likely to affect the results of the trial, including but not limited to a history of circulatory, respiratory, endocrine, nervous, digestive, urinary, or hematologic, immune, psychiatric, or metabolic diseases; 11. with a history of adrenal insufficiency, adrenal tumors, or hereditary heme biosynthesis disorders; 12. a history of severe cardiovascular disease, including but not limited to organic heart disease, such as heart failure, myocardial infarction, angina pectoris, or malignant arrhythmia, as judged by the investigator; Such as a history of torssion ventricular tachycardia, ventricular tachycardia, long QT syndrome or symptoms of long QT syndrome and family history (as indicated by genetic evidence or sudden death of a close relative at a young age due to cardiac causes); 13. underwent any surgery within 6 months before screening; 14. allergic constitution, such as known allergic history to two or more substances; Or who, as judged by the investigator, may be allergic to the trial drug or its excipients; Living habits: 15. heavy drinking or regular drinking in the 6 months before screening, i.e. drinking more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of 40% spirits or 150 mL of wine); Or with a positive alcohol breath test during the screening period; 16. used nicotine-containing products between 3 months before screening and study enrollment; 17. with drug abuse or drug abuse history within 3 months before screening; Or the urine drug test was positive in the screening period; 18. habitual consumption of grapefruit juice or excessive tea, coffee and/or caffeinated beverages and inability to quit during the trial; Others: 19. who had difficulty in blood collection or could not tolerate blood collection by venipuncture; 20. participated in any other clinical trial (including drug and device clinical trials) within 3 months before screening; 21. vaccinated within 1 month before screening or planned to be vaccinated during the trial period; 22. pregnant or lactating women; 23. during the trial and within half a year after the completion of the trial, or those who do not agree that the subjects and their spouses should take strict contraceptive measures during the trial and within half a year after the completion of the trial (see Appendix 4 for details); 24. had blood loss or donation \> 400 mL within 3 months before screening, or received blood transfusion within 1 month; 25. had any factors considered by the investigator to preclude participation in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameters | from 1 hour before administration of et-26 until 24 hours after the end of administration. | Cmax |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MOAA/S | up to 10 minutes after drug administration | modified observer's assessment of alert（MOAA/S） score: The lowest score was 0, indicating full anesthetic sedation, and the highest score was 5, indicating full consciousness. |
| Eyelash reflex | up to 2 minutes after drug administration | Gently touching the subject's eyelashes with a cotton swab can cause the subject to blink, that is, there is an eyelash reflex. When the eyelash reflex disappears, the patient has entered a state of anesthesia |
Countries
China
Outcome results
None listed